Active, Not Recruiting
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment - IM011-055
Updated: 29 February, 2024 | ClinicalTrials.gov
Phase
Gender(s)
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Active, Not Recruiting
Inclusion Criteria: - Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening - Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening - Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening - Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1 - Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening - Must have completed the week 52 treatment for the optional open-label long-term extension period Exclusion Criteria: - Nonplaque psoriasis at Screening or Day 1 - Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis - History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease) - Active fibromyalgia - Received an approved or investigational biologic therapy for the treatment of PsA or PsO Other protocol-defined inclusion/exclusion criteria apply
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